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BioFire Diagnostics, LLC. Staff Scientist in San Jose, California

Company Overview:

bioMérieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving patient outcomes. We are seeking a highly skilled Automation and Verification Engineer to join our dynamic team, driving robustness of hardware, software, firmware, and algorithms into systems that shape the future of medical science.

Job Overview:

As a Staff Scientist in the Microbiology Department, you play a crucial role in supporting the development of AST products. Your responsibilities span both laboratory work and collaboration with software and system engineering teams to ensure seamless integration of AST assays on the Vitek Reveal platform. You contribute to building and documenting tools, ensuring precise and dependable AST assay results to guide patient therapy. Strong communication, organizational, and troubleshooting skills are essential, along with the ability to work both independently and collaboratively.

Primary Duties

  • Collaborate closely with the software, hardware development and system engineering teams, as well as other functions, to support menu products on the Vitek Reveal.

  • Implement the use of BioMérieux software solutions within the department and support their integration on the Vitek Reveal platform

  • Contribute to the development of tools for analyzing large performance data sets generated from AST experiments. Additionally describe and detail use cases for the software team.

  • Establish and maintain configuration management processes for systems and software and ensure version control and traceability of software releases within the microbiology department.

  • Support biological testing needed for software validation and system verification activities.

  • Troubleshoot technical issues specific to the AST tests/system, record and report these issues cross-functionally, and provide suggestions and resolutions for investigations.

  • Prepare bacterial cultures and perform AST experiments using clinical bacterial isolates.

  • Collaborate with other scientists and managers to optimize testing protocols and workflows within the lab.

  • Maintain accurate records of experiments and results, write work instructions (WIs), standard operating procedures (SOPs), protocols, reports, process flows etc...

  • Ensure compliance with regulatory standards (e.g., FDA, ISO) and comply with biohazard safety standards.

  • Participate in product risk assessment, technical design reviews and critically evaluate design and implementation plans

  • Summarize findings and present results to cross-functional teams.

  • Mentor and train new and existing team members and be a technical advisor for data analysis problems

  • Propose and explore novel approaches/tools to enhance testing accuracy and efficiency.

    Knowledge, Experience and Skills

  • M.S. with 8+ years or PhD with 5+ years relevant experience in Microbiology, Bioengineering, or related field

  • Demonstrated proficiency in AST methods (broth microdilution, disk diffusion, etc.) desirable.

  • Familiarity with bacterial identification systems (MALDI-TOF, PCR)

  • Understanding of regulatory and compliance requirements for IVD products (e.g., QSR, ISO, GLP).

  • Programming skills (Python, R, or similar) for data analysis

  • Familiarity with data visualization/analysis software such as Tableau, JMP or Minitab. Strong proficiency in the use of MS office suite

  • Excellent communication (verbal and written) abilities and collaboration skills.

  • Strong organizational skills, decision making, communication, teamwork, and troubleshooting skills.

  • Ability thrive in challenging fast-paced multidisciplinary environment with focus on meeting tight deadlines and delivering high quality results.

  • Ability to work both independently with minimal guidance or oversight as well as in tandem with all levels of corporate personnel.

  • Make sound, well-informed judgments with the quality of product at the top of their mind when forming decisions. Lead by example and reinforcing corporate values that lead to the success of the department.

    The estimated salary range for this role based in California is between $ 135,900 and $ 177,200 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

    In addition, bioMérieux offers a competitive Total Rewards package that may include:

  • A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options

  • Company-Provided Life and Accidental Death Insurance

  • Short and Long-Term Disability Insurance

  • Retirement Plan including a generous non-discretionary employer contribution and employer match.

  • Adoption Assistance

  • Wellness Programs

  • Employee Assistance Program

  • Commuter Benefits

  • Various voluntary benefit offerings

  • Discount programs

  • Parental leaves

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